510(k) · Cleared
ClearedThera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Nov 21, 2007 as substantially equivalent to K913368 (Fisher & Paykel Electronics, Ltd., 1992) and 1 other predicate after a 128-day review. Its family tree reaches back 1 generation to 1992. 8 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 128 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913368 (1992). 2 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- This deviceK071958 Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated…Smiths Medical Asd, Inc. · 2007
- Descendant · cites it directly · 6 of its ownK100104 Hybernite Rainout Control SystemPlastiflex Group NV · 2010
- Descendant · 2 generations on · 3 of its ownK110398 Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011
- Descendant · 3 generations on · 2 of its ownK140424 Respironics Reusable Heated TubingRespironics, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK092256 Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075…Smiths Medical Asd, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK122705 Humicare D900Grundler GmbH · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K100104Hybernite Rainout Control SystemPlastiflex Group NV · 2010 · cites it directly6descendants
- K110398Respironics Disposable Heated Wire CircuitsRespironics, Inc. · 2011 · 2 generations on3descendants
- K140424Respironics Reusable Heated TubingRespironics, Inc. · 2014 · 3 generations on2descendants
- K092256Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012Smiths Medical Asd, Inc. · 2010 · cites it directly2descendants
- K122705Humicare D900Grundler GmbH · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| 0 (this device) | K071958 | Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire… | Smiths Medical Asd, Inc. | 2007 | — |
| +1 | K100104 | Hybernite Rainout Control System | Plastiflex Group NV | 2010 | — |
| +2 | K110398 | Respironics Disposable Heated Wire Circuits | Respironics, Inc. | 2011 | — |
| +3 | K140424 | Respironics Reusable Heated Tubing | Respironics, Inc. | 2014 | — |
| +1 | K092256 | Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012 | Smiths Medical Asd, Inc. | 2010 | — |
| +2 | K122705 | Humicare D900 | Grundler GmbH | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTT device
- #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid AccSummary page 1…Classification Name: Humidifier, Respiratory Gas Heater (21 CFR 868.5450, Product Code BTT) & Breathing System (21 CFR 868.5270, Product Code BZE) Predicate Device(s): K913368, (Fisher & Paykel Electronics Ltd.) Models MR700/MR720/MR730 Dual Servo Respiratory Humidifier ACC K000697, [Cardinal Health (for… | 1992 |
| * | K000697 | Modification to Airlife Heated Ventilator and Anesthesia Breathing CircuitsSummary page 1…tem (21 CFR 868.5270, Product Code BZE) Predicate Device(s): K913368, (Fisher & Paykel Electronics Ltd.) Models MR700/MR720/MR730 Dual Servo Respiratory Humidifier ACC K000697, [Cardinal Health (formerly Allegiance Healthcare Corp)], Airlife® Heated Ventilator and Anesthesia Breathing Circuits Device De… | 2000 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All BTT devicesBTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · BTT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTT
104in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTT
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BTT
1,743in 2025
MAUDE reports naming product code BTT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 73 | 1 | 365 |
| 2008 | 4 | 199 | 1 | 456 |
| 2009 | 1 | — | 0 | 558 |
| 2010 | 4 | 113 | 2 | 562 |
| 2011 | 3 | 116 | 1 | 665 |
| 2012 | 2 | — | 0 | 583 |
| 2013 | 6 | 171 | 0 | 718 |
| 2014 | 7 | 231 | 5 (4) | 718 |
| 2015 | 1 | — | 0 | 670 |
| 2016 | 3 | 157 | 0 | 1,094 |
| 2017 | 3 | 303 | 0 | 1,007 |
| 2018 | 2 | — | 0 | 918 |
| 2019 | 1 | — | 0 | 894 |
| 2020 | 2 | — | 0 | 1,188 |
| 2021 | 2 | — | 0 | 1,510 |
| 2022 | 3 | 290 | 0 | 749 |
| 2023 | 7 | 258 | 0 | 716 |
| 2024 | 7 | 219 | 0 | 501 |
| 2025 | 4 | 104 | 1 | 1,743 |
| 2026 | 4 | 184 | 1 | — |
What is it indicated for?
The Smiths Medical Thera-HeatTM Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases The Smiths Medical Thera-HeatTM Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers. An adult…
Read the full statement (192 words)
The Smiths Medical Thera-HeatTM Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases
The Smiths Medical Thera-HeatTM Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.
An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-HeatTM Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-HeatTM Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071958 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071958: Thera-Heat Heated Humidifier and Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071958
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026